Shares of CytRx bounced up 10% this morning as investors responded to the news that the FDA had lifted its partial hold on its late-stage cancer drug aldoxorubicin.
The LA-based biotech ($CYTR) had been hit with an order to stop enrollment back in November following the death of a patient taking the drug under compassionate use rules. This morning the developer said that it was able to modify the study to the satisfaction of regulators, but didn't spell out exactly what those changes were.
|CytRx CEO Steven Kriegsman|
"CytRx developed modified study parameters intended to avoid potential risks, while allowing the company to evaluate the therapeutic impact of aldoxorubicin for patients with soft tissue sarcoma, glioblastoma, Kaposi's sarcoma, and small cell lung cancer, among other trials," said Steven A. Kriegsman, CEO of CytRx, in a statement. "Our staff worked closely with the FDA Oncology Division to resolve all partial clinical hold issues as rapidly as possible. We expect enrollment and dosing in the ongoing clinical trials to be back underway soon."
CytRx has placed just about all of its pipeline eggs in the aldoxorubicin basket.
The two-month delay won't significantly alter the biotech's development timeline, according to the release. Enrollment in the pivotal study for second-line soft tissue sarcoma is expected by the end of 2015, with investigators unblinding the data at the midway point in 2016. And if all goes according to their hope, little CytRx--which has a market cap of $196 million-- says it could be in a position to launch in 2017.
The drug is a modified form of doxorubicin, a well-known and toxic chemo agent. Researchers use a linker that attaches the drug to circulating protein called albumin, which in turn is gobbled up by hungry tumors. And it's designed to release the drug in the tumor, while staying benign in healthy tissue. This new approach is supposed to allow for higher, more effective dosing to fight the cancer.
- here's the release